Active Ingredient: Semaglutide
Semaglutide is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise in addition to other medicinal products for the treatment of diabetes.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Subcutaneous, 0.25 milligrams semaglutide, once weekly, over the duration of 4 weeks. Afterwards, subcutaneous, between 0.25 milligrams semaglutide and 2 milligrams semaglutide, once weekly. The maximum allowed total dose is 2 milligrams semaglutide weekly.
The starting dose is 0.25 mg semaglutide once weekly. After 4 weeks the dose should be increased to 0.5 mg once weekly. After at least 4 weeks with a dose of 0.5 mg once weekly, the dose can be increased to 1 mg once weekly to further improve glycaemic control. After at least 4 weeks with a dose of 1 mg once weekly, the dose can be increased to 2 mg once weekly to further improve glycaemic control.
Semaglutide 0.25 mg is not a maintenance dose. Weekly doses higher than 2 mg are not recommended.
When semaglutide is added to existing metformin and/or thiazolidinedione therapy or to a sodiumglucose cotransporter 2 (SGLT2) inhibitor, the current dose of metformin and/or thiazolidinedione or SGLT2 inhibitor can be continued unchanged.
When semaglutide is added to existing therapy of sulfonylurea or insulin, a reduction in the dose of sulfonylurea or insulin should be considered to reduce the risk of hypoglycaemia.
Self-monitoring of blood glucose is not needed in order to adjust the dose of semaglutide. Blood glucose self-monitoring is necessary to adjust the dose of sulfonylurea and insulin, particularly when semaglutide is started and insulin is reduced. A stepwise approach to insulin reduction is recommended.
If a dose is missed, it should be administered as soon as possible and within 5 days after the missed dose. If more than 5 days have passed, the missed dose should be skipped, and the next dose should be administered on the regularly scheduled day. In each case, patients can then resume their regular once weekly dosing schedule.
The day of weekly administration can be changed if necessary, as long as the time between two doses is at least 3 days (>72 hours). After selecting a new dosing day, once-weekly dosing should be continued.
No dose adjustment is required based on age. Therapeutic experience in patients ≥75 years of age is limited.
Semaglutide is to be injected subcutaneously in the abdomen, in the thigh or in the upper arm. The injection site can be changed without dose adjustment. Semaglutide should not be administered intravenously or intramuscularly.
Semaglutide is to be administered once weekly at any time of the day, with or without meals.
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